Meeting the Needs of Young Hispanic Autistic Children (NCT06733584) | Clinical Trial Compass
RecruitingNot Applicable
Meeting the Needs of Young Hispanic Autistic Children
United States200 participantsStarted 2025-09-22
Plain-language summary
Purpose of the Study: The goal of this clinical trial is to find out if a technique called the "mutual gaze procedure" used in a Culturally and Linguistically Responsive adaptation of Pathways Early Intervention (CLR-Pathways) is the key to improving social communication, language, and everyday skills in young (18-42 months) Hispanic autistic children experiencing low income.
What Will Happen: Researchers will compare two versions of CLR-Pathways.
* Version 1: Includes mutual gaze strategies.
* Version 2: Does not include mutual gaze strategies.
What to Expect: Participants will:
* Attend 16 sessions (or 18 weeks if there are cancellations) of Pathways Intervention, each lasting 1.5 hours.
* Come to the clinic for a developmental check-up three times: before starting Pathways, right after completing Pathways, and three months after finishing Pathways.
Who can participate
Age range
18 Months – 42 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Children must be from a Hispanic family experiencing low income, defined as having an income-to-needs ratio of \< 320% of the federal poverty level, determined by their household size
* Children must be between 18-42 months old at the start of the study
* Children must have no other known neurological or genetic concerns or disorders determined by parent report
* Children must receive a Calibrated Severity Score (CSS) of 4 or higher on the Autism Diagnostic Observational Schedule-2 (ADOS-2) administered by a qualified bilingual assessment associate
* Families must have a primary home language of English and/or Spanish
Exclusion Criteria:
* Children who are from a family that is not Hispanic and/or does not have an income-to-needs ratio of \< 320% of the federal poverty level, determined by their household size
* Children younger than 18 months or older than 42 months at the start of the study
* Children whose parents report they have any other known neurological or genetic concerns or disorders
* Children who receive a Calibrated Severity Score (CSS) lower than 4 on the ADOS-2
* Families who do not have English or Spanish as a primary home language
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Respeto
Timeframe: At baseline (i.e., within two weeks prior to the start of intervention); Post-intervention (i.e., within two weeks after completing the intervention); At three-month follow-up
2
Change in Social Communication Skills
Timeframe: At baseline (i.e., within two weeks prior to the start of intervention); Post-intervention (i.e., within two weeks after completing the intervention); At three-month follow-up
3
Change in Adaptive Functioning
Timeframe: At baseline (i.e., within two weeks prior to the start of intervention); Post-intervention (i.e., within two weeks after completing the intervention); At three-month follow-up
4
Change in Social Attention
Timeframe: At baseline (i.e., within two weeks prior to the start of intervention); Post-intervention (i.e., within two weeks after completing the intervention); At three-month follow-up
5
Change in Intentional Communication
Timeframe: At baseline (i.e., within two weeks prior to the start of intervention); Post-intervention (i.e., within two weeks after completing the intervention); At three-month follow-up
Timeframe: At baseline (i.e., within two weeks prior to the start of intervention); Post-intervention (i.e., within two weeks after completing the intervention); At three-month follow-up